CULPRIT-SHOCK Clinical Trial – Review

CULPRIT-SHOCK Clinical Trial – Review

Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial investigated two strategies for percutaneous coronary interventions (PCI) in acute myocardial infarction with cardiogenic shock [1]. It was a multicenter randomized trial involving 706 patients who were randomized to either immediate PCI of the culprit lesion only with option for staged PCI of non-culprit lesions or immediate multivessel PCI. Primary composite endpoint included death and severe renal failure leading to renal replacement therapy within 30 days after randomization. Primary composite endpoint was lower in those who initially underwent culprit lesion only PCI.

There was no difference in the time to hemodynamic stabilization, need and duration of catecholamine therapy, levels of troponin T and creatinine kinase, rates of bleeding and stroke between the two groups. All-cause mortality was 43% in the culprit lesion only PCI group while it was 51.6% in the multivessel PCI group. The rate of renal-replacement therapy was similar in both groups 11.6% and 16.4%, respectively.

Higher dose of contrast needed for multivessel PCI is one possible reason for poor outcome in multivessel PCI. But renal outcome was not significantly different in the two groups. Higher dose of contrast can also lead to acute left ventricular volume overload and consequent negative effect on myocardial function and recovery. Prolonged procedure in case of multivessel PCI in a hemodynamically compromised patient is another potential cause for poorer outcome. 

Based on CULPRIT-PCI trial results, 2018 ESC/EACTS Guidelines on myocardial revascularization downgraded immediate multivessel PCI in cardiogenic shock to Class IIIB recommendation [2]. Class IIIB means that the procedure is not useful and may be harmful, based on the evidence from a single randomized trial.

One year outcomes published later showed that mortality did not differ significantly between the two groups at 1 year of follow up [3]. But the rates of rehospitalization for heart failure and repeat revascularization were higher in the culprit-lesion only PCI group than the multivessel PCI group at 1 year. The rates of rehospitalization for heart failure in both groups were low and the absolute difference between the groups was small. It is not sure whether this difference was due to mortality bias.

Previous randomized trials for cardiogenic shock had shown that death was mostly confined to the first 30 days. Mortality between 30 days to 1 year was 6.6% in CULPRIT-SHOCK trial. This compares well with other trials in cardiogenic shock. Corresponding mortality in Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial was 6.6% [4] and in the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial it was 12.3% [5].

References

1. Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. 
2. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165.
3. Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. 
4. Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, LeJemtel TH; SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001 Jan 10;285(2):190-2. 
5. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Böhm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45.